Recall Z-2609-2026

Medline Industries, LP · initiated May 28, 2026

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B

Codes / lots: DYNJ905855 UDI-DI 10193489546606 Lots 21ABU297 21BBB235 21DBV520 21FBG162 21GBC672 21GBI192 21IBT387 21VBB580 22DBK812 22FBR093 22FBS035 22HBI628 22IBV291 22JBX729 22NBE430 23ABD954 23BBI465 23CBO951 23CBX474 23GBF721 DYNJ905857 UDI-DI 10193489545678 Lots 21ABG510 21GBK940 DYNJ905936B UDI-DI 10193489422818 Lots 21BBF766 21DBP452 21FBF248 21LBJ459 22ABV319 22DBS751 22FBU868

Reason for recall

Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.

FDA-determined cause: Process change control

Action taken

On May 28, 2026, the firm notified customers via letters titled "URGENT MEDICAL DEVICE CORRECTION." Customers were referred to BD's recall notice, which provides advice for users and instructions to mitigate hub breakage issues. Product return is not required. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Details

Recall number
Z-2609-2026
Initiated
May 28, 2026
Posted by FDA
June 26, 2026
Product code
LRO – General Surgery Tray
Quantity
9,272 kits
Distribution
US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.
Recalling firm
Medline Industries, LP, Northfield, IL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2606-2026 Class IIMedline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK…Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of… 05/28/2026Open, Classified
Z-2607-2026 Class IIMedline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR…Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of… 05/28/2026Open, Classified
Z-2608-2026 Class IIMedline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL…Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of… 05/28/2026Open, Classified
Z-2610-2026 Class IIMedline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM…Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of… 05/28/2026Open, Classified
Z-2611-2026 Class IIMedline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B…Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of… 05/28/2026Open, Classified
Z-2612-2026 Class IIMedline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK…Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of… 05/28/2026Open, Classified
Z-2613-2026 Class IIMedline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K…Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of… 05/28/2026Open, Classified